NOBIVAC® RL

NOBIVAC® RL
Reg. No. G2199 (Act 36/1947)
Namibia Reg. No. V97/24.1/891 NS0

FOR ANIMAL USE ONLY

Only for use by or under the supervision of persons registered or authorized in terms of section 23(1)(c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982)

INDICATIONS

Nobivac® RL is an inactivated vaccine for the active immunisation of healthy dogs against rabies and canine leptospirosis caused by Leptospira interrogans serogroups Canicola and Icterohaemorrhagiae.

COMPOSITION

Each 1 mℓ dose of Nobivac® RL contains at least 3 IU, as measured in the mouse potency test, of Rabies virus strain Pasteur RIV, grown on cell culture and inactivated with BPL, as well as BPL-inactivated Leptospira interrogans serogroups Canicola, strain Ca-12-000 ≥ 40 hamster PD80 and Icterohaemorrhagiae, strain 820K ≥ 40 hamster PD80 with aluminium phosphate as an adjuvant and thiomersal as a preservative.

STORAGE

  • Store in the dark between 2 °C and 8 °C.
  • Do not freeze.
  • Allow the vaccine to reach room temperature (20 °C – 25 °C) gradually before use.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
  • Protect from direct sunlight.

WARNINGS

  • Occasionally a mild hypersensitivity reaction may occur after vaccination as is possible after administration of any foreign protein. Such reactions are in most cases self-limiting. A local reaction of limited size may arise during the first few days after vaccination.
  • Destroy any unused, reconstituted vaccine, empty vaccine containers, needles, etc., according to local waste disposal regulations, after the completion of vaccination.
  • Use the entire contents of the multi dose vial within one working day. Do not store partially used vaccine containers for future use.
  • Nobivac® RL can be used to reconstitute the freeze-dried live Nobivac® canine vaccines (No information is available on the effects of the concurrent use with any other vaccines. It is therefore recommended that vaccines other than the live Nobivac® canine vaccines are not administered within 14 days before or after vaccination).
  • KEEP OUT OF REACH OF CHILDREN AND UNIFORMED PERSONS.
  • Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

  • Vaccinate healthy dogs only.
  • Adequate clinical examination should be done prior to inoculation.
  • Following vaccination, contact with potential sources of infection should be avoided until 14 days after inoculation.
  • Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc.) are clean and sterile prior to use.
  • Ensure that all the vaccination equipment remains clean and sterile during the vaccination.
  • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • Allow the vaccine to gradually reach room temperature between 20 °C and 25 °C before use.
  • Shake well before use.
  • Give 1 mℓ subcutaneously in the neck or chest region.
  • Nobivac® RL may be mixed or may be used as a diluent for Nobivac® DHP, Nobivac® Parvo-C, Nobivac® DHPPi or Nobivac® Corona.

Vaccination programme

The primary vaccination against rabies is a single administration not given before 12 weeks of age. The primary vaccination may be administered at an earlier age, but then a repeat vaccination must be given at approximately 12 weeks, 2 to 4 weeks after the first vaccination.

The primary vaccination against leptospirosis should consist of two vaccinations, 2 to 4 weeks apart. Puppies should be at least 8 weeks of age before they receive the first vaccination against leptospirosis.

Therefore Nobivac® RL can be used under the following circumstances:

  • Puppies (early start)

Age 8/9 weeks            Nobivac® Lepto or Nobivac® RL (in case of possible early exposure to rabies)

Age 12 weeks             Nobivac® RL (repeat vaccination with rabies to ensure protection of puppies with maternal immunity against rabies).

  • Primary vaccination at any age 12 weeks

Age 12 weeks            Nobivac® RL

Age 14/15 weeks        Nobivac® Lepto

Proposed vaccination schedule

Depending on the local situation and the maternal immunity status of the animal, a choice can be made from the following vaccination programmes:

  1. No direct infection risk:

Age 9 weeks               Nobivac® Lepto and Nobivac® DHPPi

Age 12 weeks             Nobivac® DHPPi and Nobivac® RL

In healthy dogs this programme will provide full protection against all components included.

  • Risk of parvovirus infection in weaned puppies

Age 9 weeks               Nobivac® DHPPi and Nobivac® Lepto

Age 12 weeks             Nobivac® DHPPi and Nobivac® RL

The first vaccination at 9 weeks will protect 90 % of the pups against parvovirus disease. The second vaccination will provide full protection against all components included.

  • Risk of parvovirus and distemper infection in non-weaned puppies:

Age 6 weeks               Nobivac® Puppy DP

Age 9 weeks               Nobivac® DHPPi and Nobivac® Lepto

Age 12 weeks             Nobivac® DHPPi and Nobivac® RL

The first vaccination at 6 weeks will provide protection against parvovirus disease in 75 % of the pups, the second vaccination will increase this percentage to 95 %, and the third vaccination will provide full protection against all components.

Revaccination

Revaccination against rabies should be given every 3 years but local regulations may require earlier revaccination.

Revaccination against leptospirosis is needed every year. It is advocated to [re]vaccinate against leptospirosis in the spring because infections with Leptospirae occur most frequently during [late] summer, and to give dogs that are often in natural water a third leptospirosis vaccination 6 months after the basic vaccination.

  • Revaccinations

Yearly against leptospirosis               Nobivac® Lepto

Every 3 years against rabies  Nobivac® RL (or sooner to comply with local regulations).

PRESENTATION

Polyethylene terephthalate (PET) tray containing 10 single dose vials.

Multi dose vials containing 10 doses.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd

20 Spartan Road, Spartan

1619, RSA

Tel: +27 (0) 11 923 9300

Fax: +27 (0) 11 392 3158

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

13 September 2006